ANDA 209614

ACTAVIS LABS FL INC

FDA Drug Application

Application #209614

Documents

• Letter: 2019-04-24

Application Sponsors

ANDA 209614

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

40MG

0

ENZALUTAMIDE

ENZALUTAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-03-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209614
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENZALUTAMIDE","activeIngredients":"ENZALUTAMIDE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209614Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-14
        )

)